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Post by cretin11 on Oct 2, 2017 15:43:17 GMT -5
You can post as many links as you want, but NONE of them so far have specifically indicated that INSULIN production has been shut down. Again, that is the specific claim you made that I asked you to prove. But, please, at this point just forget I asked. I read the articles too and don't see any mention of insulin. itellthefuture777 it would be better if youwouldtellthetruth. Seriously, your optimism is great (and i'm pulling for you to be right one day) but it's like the boy who cried wolf, difficult to know when to put any credence in what you post. |
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Post by lakers on Oct 2, 2017 15:45:10 GMT -5
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Post by porkini on Oct 2, 2017 15:54:44 GMT -5
Surely not the official new - the last page... "Distributed by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807 A SANOFI COMPANY Approved: 09/2015" ? ? ? |
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Post by dreamboatcruise on Oct 2, 2017 16:00:33 GMT -5
People's pancreases do not operate as well under extreme duress and stress, they had plenty of that in Puerto Rico, therefore, insulin production is down. (Just a theory, but makes some sense) When you don't have food... insulin production definitely goes down. |
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Post by peppy on Oct 2, 2017 16:09:50 GMT -5
the official new label already needs revision. page 25.
Manufactured by:
MannKind Corporation
Danbury, CT 06810
Distributed by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
Approved: 09/2015
Page 13; MannKind Corporation
Danbury, CT 06810
Distributed by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
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Post by porkini on Oct 2, 2017 16:13:17 GMT -5
Surely not the official new - the last page... "Distributed by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807 A SANOFI COMPANY Approved: 09/2015" ? ? ? the official new label already needs revision. page 25.
Manufactured by:
MannKind Corporation
Danbury, CT 06810
Distributed by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
Approved: 09/2015
Page 13; MannKind Corporation
Danbury, CT 06810
Distributed by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
If we show them enough times, someone is bound to notice!  |
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Post by esstan2001 on Oct 2, 2017 16:13:22 GMT -5
the official new label already needs revision. page 25.
Manufactured by:
MannKind Corporation
Danbury, CT 06810
Distributed by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
Approved: 09/2015
Page 13; MannKind Corporation
Danbury, CT 06810
Distributed by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
I caught that too... You would have thought after a year the F-Dee-lAy would get that sorted...What a wonderful bureaucracy we fund! |
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Post by lakers on Oct 2, 2017 16:29:45 GMT -5
Already sent a note to those in charge. Stay tune.
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Post by od on Oct 2, 2017 16:40:32 GMT -5
the official new label already needs revision. page 25.
Manufactured by:
MannKind Corporation
Danbury, CT 06810
Distributed by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
Approved: 09/2015
Page 13; MannKind Corporation
Danbury, CT 06810
Distributed by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
I caught that too... You would have thought after a year the F-Dee-lAy would get that sorted...What a wonderful bureaucracy we fund! ...and perhaps MNKD could have participated in 'sorting it out'. |
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Post by esstan2001 on Oct 2, 2017 17:38:48 GMT -5
I caught that too... You would have thought after a year the F-Dee-lAy would get that sorted...What a wonderful bureaucracy we fund! ...and perhaps MNKD could have participated in 'sorting it out'. Contrary to what one may think, dealing with the FDA is not a very interactive process. You request a meeting with them to discuss a particular topic, wait to get scheduled onto the calendar, then have your meeting and hope everything gets addressed. These pains are taken to preserve the independence, impartiality, and avoid influence on a governing agency. There was likely a suggestion for the label, but not necessarily any company review. The FDA generates the label. If multiple of us message board weenies could pick out these 2x instances at a glance, don't you think company staff tasked with the responsibility to ensure things are clearly communicated to the FDA would not have caught this? |
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Post by od on Oct 2, 2017 17:46:48 GMT -5
...and perhaps MNKD could have participated in 'sorting it out'. Contrary to what one may think, dealing with the FDA is not a very interactive process. You request a meeting with them to discuss a particular topic, wait to get scheduled onto the calendar, then have your meeting and hope everything gets addressed. These pains are taken to preserve the independence, impartiality, and avoid influence on a governing agency. There was likely a suggestion for the label, but not necessarily any company review. The FDA generates the label. If multiple of us message board weenies could pick out these 2x instances at a glance, don't you think company staff tasked with the responsibility to ensure things are clearly communicated to the FDA would not have caught this? As a retired senior executive at a top 5 pharmaceutical company, I would be surprised to learn that the new published label was 'dropped' on MNKD. Sure, anyting can happen. |
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Post by mnkdfann on Oct 2, 2017 18:38:24 GMT -5
If multiple of us message board weenies could pick out these 2x instances at a glance, don't you think company staff tasked with the responsibility to ensure things are clearly communicated to the FDA would not have caught this? I'm reminded of when the C-level officers at MNKD forgot to release the NASDAQ notification of deficiency to the public (and MNKD shareholders) within the allotted time. |
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Post by lakers on Oct 2, 2017 19:08:47 GMT -5
Rose replied:
Our Regulatory Executive had already followed up with the FDA to clarify what the label update would impact.
The approval letter reflects all supplemental NDA approvals (PAS) – they are the documents through the AFREZZA NDA lifecycle that FDA has approved whether MannKind or Sanofi was listed as sponsor. All current labeling that will be posted on DailyMed and on http://www.afrezza.com<http://www.afrezza.com/> will not show Sanofi.
Further, according to the FDA, those pieces with Sanofi references will still remain in the corrected labeling that the FDA sends us as they would in the postings at Drugs@FDA. Having all the pieces attached to the new letter is just a way to keep all of the labeling that has been approved together.
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Post by MnkdWASmyRtrmntPlan on Oct 2, 2017 20:21:28 GMT -5
I didn't realize that the storage instructions were so stringent:
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Storage
Not in Use: Refrigerated Storage 2–8ºC (36–46ºF)
* If a foil package, blister card or strip is not refrigerated, the contents must be used within 10 days.
Sealed (Unopened) Foil Package May be stored until the Expiration Date*
Sealed (Unopened) Blister Cards + Strips May be stored for 1 month*
In Use: Room Temperature Storage 25ºC (77ºF), excursions permitted 15–30ºC (59–86ºF)
Sealed (Unopened) Blister Cards + Strips Must be used within 10 days
Opened Strips Must be used within 3 days
Do not put a blister card or strip back into the refrigerator after being stored at room temperature.
Inhaler Storage:
Store at 2–25ºC (36–77ºF); excursions permitted. Inhaler may be stored refrigerated, but should be at room temperature before use.
Handling:
Before use, cartridges should be at room temperature for 10 minutes.
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Post by MnkdWASmyRtrmntPlan on Oct 2, 2017 20:34:17 GMT -5
And here's the big ACTION word that we have all been waiting for:
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1 INDICATIONS AND USAGE
AFREZZA® is a rapid acting inhaled insulin indicated to improve glycemic control in adult
patients with diabetes mellitus.
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